12 results
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37ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CABLING SYSTEM TROCHANTER HOOK
FDA 510(k)
FDA Class 2
·Orthopedic
ZAAG
FDA UDI
Zest Anchors, LLC·00840481109256·ZAAG Denture Cap Male (Mini) (2 Pack)
PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET
FDA 510(k)
FDA Class 2
·Anesthesiology
COMPLETE BRAND MULTI-PURPOSE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 9, 2013
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·March 15, 2011
ENDOTAK RELIANCE G
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
32MM MOD HEAD COCR -6MM NECK
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·April 1, 2020
TI LOW PROFILE SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·February 20, 2019
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
FDA Enforcement
Class I
·Ongoing·Thoratec Corp.·May 8, 2024
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012